the left ventricular assist device (lvad) off or on pump implantation study

Conditions: Heart Failure; LVAD

Summary: the purpose of this study is to compare adverse events after off-pump lvad surgery or on-pump lvad surgery.


Eligibility criteria:
inclusion criteria: * the patient has had a diagnosis of end stage heart failure, new york heart association (nyha) class iii or iv hf for a minimum of 90 days prior to screening. * the patient has guideline-directed medical therapy according to american college of cardiology(acc)/american heart association (aha)/european society of cardiology(esc) heart failure(hf) guidelines * the patient has an interagency registry for mechanically assisted circulatory support (intermacs) score of 1-3. * left ventricular assist device (lvad) placement is intended as a bridge to transplant (btt) or destination therapy (dt) with either heartware ventricular assist device (hvad) or heartmate iii lvad. * the patient is able to sign informed consent form and release of medical information form. * the patients is willing and able to participate in scheduled follow-up appointments. exclusion criteria: * the patient requires concomitant surgery for left ventricular or atrial appendage closure or the patient has severe aortic insufficiency, mitral stenosis, or severe tricuspid regurgitation. * the patient has an intracardiac thrombus or other mass diagnosed by echocardiography, left ventriculogram, or other imaging. * planned insertion of right ventricular(rv) support device (either temporary or permanent). * the patient has suffered an acute cardiovascular event such as acute coronary syndrome (st elevation myocardial infarction (stemi) or non-st elevation myocardial infarction (nstemi), or unstable angina, or underwent any cardiac surgery or interventional cardiac or peripheral vascular procedure within 30 days prior to lvad implantation. * the patient has had ischemic or hemorrhagic stroke as diagnosed by ct or mri within 90 days prior to study enrollment. * the patient had prior heart or other organ transplantation, or surgically implanted lvad or cardiac shunt. * the patient will likely need an immediate heart transplant due to hemodynamic instability. * the patient has had a known active malignancy or treatment for cancer within the past year except for localized prostate cancer, cervical carcinoma in situ, breast cancer in situ, or non-melanoma skin cancer that has been definitively treated. * the patient has history of any malignancy where expected survival is less than two years. past medical history of cancer is not exclusionary as long as subject has been disease-free for at least one years since the time of diagnosis and treatment. * patient has a severe co-morbidity (current need for hemodialysis or current glomerular filtration rate(gfr) ≤20 ml/minute/1.73 m2 estimated by modification of diet in renal disease( mdrd)calculation; hepatic impairment defined as liver function tests \[alanine aminotransferase (alt), aspartate aminotransferase (ast), alkaline phosphatase (alp)\] \>3x upper limit of normal within 30 days prior to lvad implantation or known objectively confirmed intrinsic liver disease (e.g., cirrhosis, chronic hepatitis b or hepatitis c virus infection)). * the patient has a known bleeding diathesis or thrombocytopenia defined as platelet count \<50,000 platelets/μl. * the patient has peri/postpartum cardiomyopathy, or is a pregnant or lactating woman, or a woman of child-bearing age not using a suitable method of contraception. * the patient, who in the absence of an implantable cardioverter defibrillator (icd) (or any implanted device capable of defibrillation), has a history of malignant ventricular arrhythmia or sustained ventricular tachycardia (vt), with sustained vt demonstrated by q wave r wave s wave (qrs) complexes wider than 120 milliseconds, lasting more than 30 seconds, and with a rate of more than 100 beats per minute on screening ecg or other data supporting this diagnosis. * recent history of psychiatric disease, including drug or alcohol abuse, that is likely to impair, in the opinion of the investigator, the subject's ability to comply with protocol-mandated procedures. * participation in any other clinical investigation that is likely to confound study results or affect study outcome

Keywords: lvad